In Fiscal Year 2024, whistleblower cases reached an all-time high of 979, signaling increased scrutiny of healthcare fraud. Just days after announcing a massive $14.6 billion healthcare fraud takedown involving 324 defendants, the Department of Justice (DOJ) and Department of Health and Human Services (HHS) launched a False Claims Act (FCA) Working Group on July 2, 2025.

This cross-agency task force is laser-focused on tightening enforcement and closing regulatory loopholes across the life sciences sector. Key targets include:

• Clinical Trials: Fraud related to consent forms, fabricated data, improper enrollment, and documentation mismanagement.
  
  
• Promotional Activities: Off-label claims, misleading speaker content, disguised kickbacks, and FTC violations.
  
  
• Pharmacy Operations: Compounding without clinical rationale, patient steering, and questionable reimbursement schemes.
  
  
• Corporate Transactions: M&A due diligence gaps that allow FCA risks to carry into deals.
  
  

Everyone from clinical research site owners and pharmacy operators to advertising managers and corporate lawyers is in the spotlight. The DOJ and HHS are encouraging voluntary self-disclosure of compliance issues, offering potential penalty mitigation—but only if disclosures are thorough and proactive.

The message is clear: life sciences companies must act now to audit their operations, re-evaluate risk, and fix known gaps before enforcement comes knocking.

At the Kulkarni Law Firm, we’re helping clients navigate this heightened enforcement landscape—whether in research, promotion, or pharmacy operations.

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